Actively Recruiting
CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study
Led by Corvivo Cardiovascular, Inc. · Updated on 2025-09-02
92
Participants Needed
2
Research Sites
224 weeks
Total Duration
On this page
Sponsors
C
Corvivo Cardiovascular, Inc.
Lead Sponsor
Y
Yale University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this pivotal study is to demonstrate the safety and performance of the Cor TRICUSPID ECM (extracellular matrix) Valve (or Cor PEDIATRIC Tricuspid ECM Valve) for the surgical management of tricuspid valve disease and dysfunction in adult and pediatric patients. The main question(s) it aims to answer are: * whether the device may be implanted successfully and safely, and * whether the device effectively treats tricuspid valve disease and dysfunction through 12 months Participants will undergo: * preoperative evaluation * tricuspid valve replacement with the Cor TRICUSPID ECM Valve * postoperative evaluation, including at hospital discharge, 30 days, 6 months, and 12 months, and then annually thereafter through 5 years
CONDITIONS
Official Title
CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures
- Patient or authorized legal guardian understands the procedure, agrees to follow-up evaluations, and provides written informed consent; pediatric patients provide assent if able
- Patient or guardian is geographically stable or willing to return for required study follow-up and agrees to all clinical protocol requirements
- Patients for whom the Cor TRICUSPID ECM Valve will be the physiological right-sided atrioventricular valve
You will not qualify if you...
- Tricuspid annulus smaller than 10mm
- Left ventricular ejection fraction less than 25%
- Mean pulmonary pressure 50mmHg or higher or pulmonary vascular resistance over 6 Woods Units
- Emergency cardiac procedures such as resuscitation or unplanned surgery
- Cardiac transplant patients
- Acute transmural myocardial infarction within 7 days causing cardiogenic shock
- Patients with a single ventricle where the valve would be the systemic atrioventricular valve
- Primary coagulopathy or uncorrected platelet disorder with platelet count less than 30,000 unless reversible by transfusion
- Significant liver disease with liver enzymes or bilirubin more than 5 times normal within 30 days unless acute and reversible
- Significant kidney dysfunction with serum creatinine over 4.0 mg/dl or GFR less than 30
- Stroke within 30 days prior to enrollment
- Major or progressive non-cardiac diseases with life expectancy under one year
- Known cancer under treatment or cancer-free for one year or less except certain skin or cervical cancers
- Hematological disorders or use of bone marrow suppressants
- Sensitivity to porcine materials
- Contraindications to aspirin or Plavix anticoagulation therapy
- Pregnant patients
- Currently enrolled in another investigational study or registry impacting this study without CorMatrix approval
AI-Screening
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Trial Site Locations
Total: 2 locations
1
St Francis Hospital
Indianapolis, Indiana, United States, 46237
Actively Recruiting
2
Columbia University Irving Medical Center/New York Presbyterian
New York, New York, United States, 10032
Actively Recruiting
Research Team
R
Robert G Matheny, MD
CONTACT
B
Brad Solberg, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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